Auburn University MRI Research Center
Auburn, Alabama, 36832, United States
Not Yet Recruiting
NCT Number: NCT07629765
Exploring How Osteopathic Manipulative Treatment May Affect Spinal Fluid Flow: An MRI Study
his study aims to investigate whether Osteopathic Manipulative Treatment (OMT) affects cerebrospinal fluid (CSF) flow and glymphatic clearance in the human brain. CSF plays an important role in brain health by supporting nutrient delivery, waste removal, and pressure regulation. Aging and certain neurological conditions are associated with reduced CSF circulation and impaired brain waste clearance.
Participants will undergo magnetic resonance imaging (MRI) scans before and after a 30-minute OMT session to evaluate changes in CSF flow dynamics and brain physiology. The study will also examine whether age, cognition, sleep quality, physical function, anxiety, and depression are associated with changes in CSF flow following OMT.
The study will enroll healthy adults between 18 and 80 years of age. Data collected from MRI imaging and questionnaires may help improve understanding of the physiological effects of OMT and its potential role in supporting brain health
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
Cerebrospinal fluid (CSF) is essential for normal central nervous system function, contributing to nutrient transport, waste clearance, and regulation of intracranial pressure. Aging is associated with reductions in CSF production, impaired glymphatic clearance, and altered CSF flow dynamics, which may contribute to cognitive decline and neurodegenerative disease processes. Although osteopathic manipulative treatment (OMT) has been proposed to influence fluid dynamics, circulation, autonomic balance, and tissue mobility, the physiological effects of OMT on CSF flow in humans remain poorly understood.
This pilot study will investigate whether OMT alters CSF dynamics and glymphatic-related imaging biomarkers in healthy adults. Thirty healthy participants will be enrolled, including individuals between 18-49 years of age and 50-80 years of age. Participants will complete MRI imaging sessions before and after a standardized 30-minute OMT session.
MRI assessments will include structural brain imaging, diffusion tensor imaging (DTI), and phase contrast MRI techniques to evaluate CSF flow, glymphatic-related diffusion metrics, and brain structural characteristics. Participants will also complete questionnaires assessing cognitive function, physical function, sleep quality, anxiety, and depression.
The study aims to:
- Determine whether CSF flow differs with aging.
- Determine whether OMT modulates CSF flow dynamics.
- Examine relationships between imaging findings and participant-reported cognitive, physical, sleep, and psychological measures.
The results of this study may improve understanding of the mechanistic effects of OMT on brain physiology and provide preliminary data for future studies evaluating OMT-related interventions targeting neurophysiological health.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Healthy adults between 18 and 80 years of age
- Able and willing to provide informed consent
- Able to safely undergo MRI procedures
- Able to participate in osteopathic manipulative treatment (OMT)
Exclusion criteria
- History of severe traumatic brain injury
- Fibromyalgia
- Epilepsy
- Severe neurodegenerative disorders
- Brain tumor or brain metastasis
- Stroke or cerebrovascular disease
- Hydrocephalus
- Brain malformations
- Demyelinating disorders
- Congenital abnormalities affecting cerebrospinal fluid (CSF) flow
- Spinal stenosis
- Prior brain surgery
- Chiari malformation
- Syringomyelia
- Other spinal conditions that may disrupt CSF flow
- Manual therapy within the previous 2 weeks
- Use of medications that affect CSF flow and/or production (including carbonic anhydrase inhibitors, furosemide, thiopental, desflurane, halothane, ketamine, etc.)
- Uncontrolled hypertension
- Uncontrolled diabetes
- MRI contraindications, including implanted metallic/electronic devices or -severe claustrophobia
- Pregnancy
Treatment and study plan
Osteopathic Manipulative Treatment (OMT)
OtherThis intervention consists of a single 30-minute osteopathic manipulative treatment (OMT) session administered by a licensed osteopathic physician trained in neuromusculoskeletal and osteopathic manipulative medicine. Treatment will be individualized based on findings from an osteopathic structural examination assessing somatic dysfunctions involving the head, spine, pelvis, extremities, and myofascial structures. Standardized OMT techniques may include osteopathic cranial manipulative medicine (OCMM), indirect method (IM), articulatory technique (ART), muscle energy technique (MET), facilitated positional release (FPR), tender point high-velocity low-amplitude (TP-HVLA), and myofascial release (MFR). The intervention is performed between pre- and post-treatment MRI sessions to evaluate acute changes in cerebrospinal fluid (CSF) dynamics and glymphatic-related imaging biomarkers.
Primary outcomes
-
Change in Cerebrospinal Fluid (CSF) Velocity Following OMT
Time frame: Immediately before and immediately after the single OMT session during the study visit.
CSF aqueductal peak and average velocity measured using phase contrast MRI before and after osteopathic manipulative treatment (OMT).
-
Change in Cerebrospinal Fluid (CSF) Flow Volume Dynamics Following OMT
Time frame: Immediately before and immediately after the single OMT session during the study visit.
CSF forward and reverse flow volumes, net forward flow, and stroke volume measured using phase contrast MRI before and after osteopathic manipulative treatment (OMT).
Secondary outcomes
-
Changes in the Diffusion Tensor Imaging Analysis along the Perivascular Space (DTI-ALPS) index
Time frame: Immediately before and immediately after the single OMT session during the study visit.
An MRI diffusion tensor imaging-based physiological measure of perivascular water diffusivity, measured before and after OMT. The DTI-ALPS assessment quantifies directional water diffusivity within white matter tracts to evaluate fluid movement along perivascular spaces.
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Correlation Between MRI-Derived CSF Flow, Velocity, and DTI-ALPS Metrics and Cognitive Function Outcomes Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Short Form and PROMIS Cognitive Abilities Short Form
Time frame: Questionnaires completed during the study visit prior to imaging procedures.
Association between changes in cerebrospinal fluid (CSF) flow and velocity metrics measured using magnetic resonance imaging (MRI) and changes in the Diffusion Tensor Imaging Analysis along the Perivascular Space (DTI-ALPS) index measured using diffusion tensor imaging (DTI) (units: quantitative CSF flow parameters, CSF velocity measures, and ALPS index ratio) and participant-reported cognitive function measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Short Form and PROMIS Cognitive Abilities Short Form (unit: PROMIS T-scores; range typically 0-100, standardized mean = 50, SD = 10; higher scores indicate better cognitive function and cognitive abilities).
Other outcomes
-
Correlation Between MRI-Derived CSF Flow, Velocity, and DTI-ALPS Metrics and Physical Function Outcomes using the PROMIS Physical Function Short Form
Time frame: Questionnaires completed during the study visit prior to imaging procedures.
Correlation between changes in cerebrospinal fluid (CSF) flow and velocity metrics measured using magnetic resonance imaging (MRI) and changes in the Diffusion Tensor Imaging Analysis along the Perivascular Space (DTI-ALPS) index measured using diffusion tensor imaging (DTI) (units: quantitative CSF flow parameters, CSF velocity measures, and ALPS index ratio) and participant-reported physical function measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form (unit: PROMIS T-scores; range typically 0-100, standardized mean = 50, SD = 10; higher scores indicate better physical function).
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Correlation Between MRI-Derived CSF Flow, Velocity, and DTI-ALPS Metrics and Sleep Quality Outcomes Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form and PROMIS Sleep-Related Impairment Short Form
Time frame: Questionnaires completed during the study visit prior to imaging procedures.
Correlation between changes in cerebrospinal fluid (CSF) flow and velocity metrics measured using magnetic resonance imaging (MRI) and changes in the Diffusion Tensor Imaging Analysis along the Perivascular Space (DTI-ALPS) index measured using diffusion tensor imaging (DTI) (units: quantitative CSF flow parameters, CSF velocity measures, and ALPS index ratio) and participant-reported sleep disturbance and sleep-related impairment measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form and PROMIS Sleep-Related Impairment Short Form (unit: PROMIS T-scores; range typically 0-100, standardized mean = 50, SD = 10; higher scores indicate worse sleep disturbance and greater sleep-related impairment).
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Correlation Between MRI-Derived CSF Flow, Velocity, and DTI-ALPS Metrics and Anxiety Symptoms using the General Anxiety Disorder-7 (GAD-7) questionnaire.
Time frame: Questionnaires completed during the study visit prior to imaging procedures.
Correlation between changes in cerebrospinal fluid (CSF) flow and velocity metrics measured using magnetic resonance imaging (MRI) and changes in the Diffusion Tensor Imaging Analysis along the Perivascular Space (DTI-ALPS) index measured using diffusion tensor imaging (DTI) (units: quantitative CSF flow parameters, CSF velocity measures, and ALPS index ratio) and participant-reported anxiety symptoms measured using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire (unit: GAD-7 total score; range 0-21, with higher scores indicating worse anxiety symptoms).
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Correlation Between MRI-Derived CSF Flow, Velocity, and DTI-ALPS Metrics and Depressive Symptoms using the Patient Health Questionnaire-8 (PHQ-8).
Time frame: Questionnaires completed during the study visit prior to imaging procedures.
Association between changes in cerebrospinal fluid (CSF) flow and velocity metrics measured using magnetic resonance imaging (MRI) and changes in the Diffusion Tensor Imaging Analysis along the Perivascular Space (DTI-ALPS) index measured using diffusion tensor imaging (DTI) (units: quantitative CSF flow parameters, CSF velocity measures, and ALPS index ratio) and participant-reported depressive symptoms measured using the Patient Health Questionnaire-8 (PHQ-8) (unit: PHQ-8 total score; range 0-24, with higher scores indicating worse depressive symptoms).
Study contacts
Contact information is provided by the study sponsor or research team.
Adil Bashir, PhD, MS
CONTACT
Daniel Cawley, DC, MS, MSHS
CONTACT
Sponsors and collaborators
Lead sponsor
Edward Via Virginia College of Osteopathic Medicine
Other
Collaborators
- Auburn University
Registry information
Official study title
Exploring the Impact of Osteopathic Manipulative Treatment on CSF Dynamics: A Mechanistic MRI-Based Investigation
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jun 5, 2026
- Registry last updated
- Jun 5, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.